Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age1+
SponsorUniversity of Rochester

About this trial

Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Mothers will be English-speaking adults, 18 years or older. (Spanish speaking adults may be included after consent document is translated and Spanish speaking study representatives are available to conduct and answer questions during informed consent process and for study follow up.)

Maternal consent must be provided for infants.

Pregnant women from the time pregnancy is confirmed until 27 weeks of gestation.

no chronic inflammatory conditions that require long-term systemic immunosuppressive medications in first or second trimester

Disqualifiers

Inability or unwillingness of subject to give written informed consent or comply with study protocol.

Known history of renal/liver/cardiac insufficiency in the mother or infant.

Pregnant women with PN or egg allergy.

Pregnant women who refuse to eat PN (or peanut products) and/or eggs.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Consumption

    Behavioral

    Subjects consume peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.

  • Avoidance

    Behavioral

    Subjects avoid eating peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Arm 1 ConsumptionActive comparator 1 intervention
Group B: Arm 2 AvoidanceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Egg or peanut sensitization

Determine the proportion of high-risk infants who have developed egg or peanut sensitization at four months (prior to introduction of these foods to the infant).

Time frame
four months

Secondary outcomes

1

Peanut and egg specific IgG and IgG4

Levels of infant peanut and egg specific IgG and IgG4

Time frame
four months
2

Antibodies in maternal blood

Quantify egg- and PN-specific IgG and IgG4 antibody concentrations in maternal blood measured during pregnancy and at four months.

Time frame
four months
3

Egg allergy

Questionnaire for parents to report any signs of egg allergy in their child.

Time frame
12 months
4

Egg and peanut specific IgE

Measure levels of infant egg- and peanut-specific IgE.

Time frame
four months

Other outcomes

1

Exploratory: Peanut sensitization

The proportion of high-risk infants who have developed peanut sensitization

Time frame
four months
2

Exploratory: Egg sensitization

Proportion of infants who develop egg sensitization.

Time frame
four months
3

Exploratory: Symptoms

Questionnaire for parents to report symptoms of non-IgE mediated food allergy

Time frame
four months
4

Exploratory: Peanut sensitization 12 months

Questionnaire for parents to report signs of peanut allergy

Time frame
12 months

Sponsors and contacts

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University of Rochester

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator